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Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus — PROGRESS  

Chronic Sinusitis Clinical Trial

Official title:
The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study

Clinical Trial Summary

The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.

Clinical Trial Description

This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02266810
Study type Interventional
Source Intersect ENT
Contact
Status Completed
Phase Phase 3
Start date September 2014
Completion date October 2016
View Details
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